DID - Dec. 22, 2009 Issue

Vol. 8 No. 247

Abbott to Pay $175 Million in Interest on Humira Patent Case Award

Abbott Laboratories will end up paying Centocor Ortho Biotech more than $1.8
billion for infringing the company’s Humira patent, including more than $175
million in interest, based on a district court decision.

The U.S. District Court for the Eastern District of Texas added the interest
to the jury award Centocor is due in the dispute in which it alleged that Abbott
willfully infringed its patent by manufacturing Humira (adalimumab), a tumor
necrosis factor alpha blocker.

A jury awarded Centocor, a Johnson & Johnson unit, $1.7 billion in a
trial in June (DID,
July
1). The drugmaker will receive about $1.2 billion in lost profits and $504
million in royalties, in addition to the interest payment ordered by the court.
Centocor owns the patent with New York University and Centocor holds an
exclusive license. The patent lawsuit was filed in the District Court in 2007.

The District Court, which upheld the judgment in a ruling last month, based
the interest payment amount on what would have been payable to Centocor on the
date the ’775 patent was first infringed in 2006, the court says in its judgment
(DID,
Nov.
9).

In May, the court ordered that the case’s equitable issues be split from the
jury trial issues. In a pre-trial brief, Abbott argued that Centocor had
misrepresented and omitted information during the jury trial regarding the
patent.

The court found that Abbott didn’t prove material misrepresentation or
omission during prosecution and the same was found true of the inventors,
attorneys or anyone else associated with the prosecution of the ’775 patent.

Abbott did not respond by press time to a request for comment on the interest
payment.

The case filed in 2007 is Centocor, Inc. and New York University v. Abbott
Laboratories.

Abbott intends to appeal the case, Scott Stoffel, a spokesman for Abbott,
told DID Monday.

"We believe this verdict is out of step with the law, the facts and the scope
of prior patent damage awards," Stoffel said. "The trial court's judgment
represents solely the end of the first round." — David Belian

Pfizer to Develop IBD Treatment With Athersys

Under the agreement, Pfizer also will provide the Ohio biopharmaceutical
company with research funding and support during the initial phase of
collaboration on MultiStem, Athersys said Monday. Pfizer will be responsible for
developing and commercializing the product.

Athersys also is eligible for milestone payments of up to $105 million and
royalties on MultiStem products for IBD. The agreement gives Athersys the option
of forgoing royalties and co-developing MultiStem products with Pfizer. The
companies would share development and commercialization costs on an agreed upon
basis beginning at Phase III clinical development, Athersys said.

MultiStem also is being developed to treat conditions including heart attack
and ischemic stroke, Athersys added. — Owen Skoler

Eli Lilly has agreed to give Incyte an upfront payment of $90 million and as
much as $665 million in milestone payments in return for the global rights to
develop and commercialize Incyte’s lead compound, INCB28050, as an oral
treatment for all inflammatory conditions.

The exclusive licensing and collaboration deal also covers Incyte’s oral
JAK1/JAK2 inhibitors and certain follow-on compounds for inflammatory and
autoimmune diseases. Incyte will receive potential royalty payments of as much
as 20 percent of sales, according to the companies. The lead compound is in a
six-month, dose-ranging Phase II trial for rheumatoid arthritis.

The agreement gives Incyte the option to co-develop its JAK1/JAK2 inhibitors
on a “compound-by-compound and indication-by-indication basis” with initiation
of a Phase IIb trial, of which Incyte would fund 30 percent, the companies add.

Incyte also has the option to co-promote products using the JAK1/JAK2
inhibitors in the U.S.

Because INCB28050 has potential applications in many treatment areas, Incyte
needed Lilly’s help with large trials and infrastructure, Paul Friedman,
Incyte’s president and CEO, told DID.— Owen Skoler

Seattle Genetics, GSK Agree to $12 Million Drug Collaboration

GlaxoSmithKline (GSK) has agreed to pay $12 million for rights to use Seattle
Genetics’ antibody-drug conjugate technology with multiple antigens.

GSK is responsible for research, product development, manufacturing and
commercialization of all antibody-drug conjugate products under the
collaboration, Seattle Genetics said Monday.

The technology is designed to spare nontargeted cells and thus reduce many of
the toxic effects of traditional chemotherapy, Seattle Genetics said.

Seattle Genetics may receive up to $390 million in milestone payments from
GSK if all antibody-drug conjugate products in the collaboration are
commercialized. The company also is eligible to receive certain royalties on net
sales of any resulting products.

The company will receive material supplies, annual maintenance fees and
research funding for assistance given to GSK. — April Hollis

Ligand, GSK Get Positive Opinion in EU for Revolade

Ligand Pharmaceuticals and GlaxoSmithKline (GSK) have received a positive
opinion for Revolade in the EU for oral treatment of thrombocytopenia in adults
with chronic immune thrombocytopenic purpura (ITP).

The European Medicines Agency’s Committee for Medicinal Products for Human
Use (CHMP) recommended Revolade (eltrombopag) for adult ITP patients who have
had their spleen removed and who do not respond to other treatments, such as
corticosteroids and immunoglobulin products. Revolade also may be considered as
a second-line treatment for adult patients when spleen removal is
contraindicated, Ligand says.

The CHMP opinion is based on two Phase III randomized, double-blind,
placebo-controlled clinical trials and two open-label studies in adults who
previously received treatment for chronic ITP, the company adds.

The studies showed patients treated with Revolade, plus the standard of care,
experienced significant increases in platelet counts, fewer bleeding incidents
and improved quality of life compared with those receiving placebo with the
standard of care. Revolade also allowed patients to reduce the dose of their
other medications, such as steroids.

ITP patients experience bruising and bleeding and sometimes serious
hemorrhages, which can be fatal, the company says.

Ligand notes GSK plans to develop Revolade, sold in the U.S. as Promacta, for
other indications but did not provide details by press time. — April Hollis

UK’s NICE Recommends Use of Cancer Drug Yondelis

PharmaMar’s cancer treatment Yondelis has received a positive recommendation
from the UK’s National Institute for Health and Clinical Excellence (NICE).

The drug was recommended for the treatment of advanced soft-tissue sarcoma, a
rare form of cancer. The treatment received the positive opinion after
Madrid-based drugmaker PharmaMar agreed to cover the cost of Yondelis when a
patient needs it after the fifth cycle of therapy, NICE said Monday.

NICE issued a draft guidance earlier this year that did not recommend
Yondelis (trabectedin) because of its cost. The company’s offer to cover some of
the price changed the decision, the agency says.

“Treatment options for this type of cancer are limited and in the last 20
years there have been no major developments to treat the advanced stages of this
disease,” Carole Longson, Health Technology Evaluation Centre director at NICE
said Monday.

The agency recommends the use of Yondelis for people with advanced
soft-tissue sarcoma when treatment with anthracyclines and ifosfamide has
failed, patients can’t tolerate the treatment or there are contraindications
against the use of anthracyclines and ifosfamide.

Soft-tissue sarcomas are tumors that develop in supporting tissues in the
body — such as fat, muscle and blood vessels — and can occur anywhere in the
body, NICE says. Trabectedin works by damaging the DNA in cancer cells, making
them unable to grow and spread. Research shows the drug can extend life by at
least three months more than other treatments currently available on the
National Health Service, according to NICE. — David Belian